A frontrunner coronavirus vaccine developed by drug giant Pfizer and German biotechnology firm BioNTech was more than 90 percent effective, said an interim analysis by an independent data monitoring committee that met on Sunday.
The interim analysis looked at the first 94 confirmed cases of coronavirus among the more than 43,000 volunteers who got either two doses of the vaccine or a placebo.
It found that fewer than 10 percent of infections were in participants who had been given the vaccine. More than 90 percent of the cases were in people who had been given a placebo.
In an announcement on Twitter, Pfizer said: “We are proud to announce, along with BioNTech Group, that our mRNA-based vaccine candidate has, at an interim analysis, demonstrated initial evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection.”
“Efficacy in the majority of participants, safety data, and consistent manufacturing are the three requirements that are needed before we are able to file for emergency use Authorization,” according to the statement.
“This is a first but critical step as we continue our work to try to deliver a safe and effective COVID19 vaccine,” the statement added.
Pfizer also said that the vaccine provided protection seven days after the second dose and 28 days after the initial dose of the vaccine. The final goal of the trial is to reach 164 confirmed cases of coronavirus infection.
The pharmaceutical giant said it plans to seek emergency use authorization from the US Food and Drug Administration soon after volunteers have been monitored for two months after getting their second dose of vaccine, as requested by the FDA.
Pfizer said it anticipated reaching that marker by the third week of November.
The Phase 3 trial of the Pfizer vaccine, made with German partner BioNTech, has enrolled 43,538 participants since July 27. As of Sunday, 38,955 of the volunteers have received a second dose of the vaccine.
The company says 42 percent of international trial sites and 30 percent of US trial sites involve volunteers of racially and ethnically diverse backgrounds.
“With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis,” Pfizer CEO Albert Bourla said in a statement.
“We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”